The Food and Drug Administration
James J. Cereghino
Abstract
In the United States, the Food and Drug Administration (FDA) is the government agency responsible for regulating biological products, drugs, and devices. The formal legal responsibility for administering these statutes is with the Secretary of the Department of Health and Human Services (HHS). This responsibility has been traditionally delegated to the FDA Commissioner, who was appointed by the HHS secretary. The FDA has published periodic compilations of drugs included in the efficacy review as part of the Drug Efficacy Study Implementation Project. For a new antiepileptic drug to be sold in the United States, the FDA must find that product safe and effective. FDA has issued regulations for Good Manufacturing Practice and Good Laboratory Practice, published and updated regularly in the FDA Compliance Program Guidance Manual. To assist investigators the FDA has developed guidelines for the format and content of the clinical and statistical sections of the New Drug Application.